Label: SKIN CLEARIFY SPOT TREATMENT- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 10, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid (1.5%)

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses

    For the treatment of acne. Dries up acne blemishes.

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the skin thoroughly with Clearify Cleanser before applying this product.
    • Apply Clearify Spot Treatment directly onto blemish with a thin layer one to three times daily.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Butylene Glycol, Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Silica, Niacinamide, Polyacrylate Crosspolymer-6, Hamamelis Virginiana (Witch Hazel) Water, Castanea Sativa (Chestnut) Seed Extract, Physalis Angulata Extract, Caprylic/Capric Triglyceride, Xanthan Gum, Disodium EDTA, Triethanolamine, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Herbalife International of America, Inc.

    800 W. Olympic Blvd., Suite 406, Los Angeles, CA 90015 USA

    Made in USA with US and imported ingredients.

    © 2016 HERBALIFE

  • PRINCIPAL DISPLAY PANEL

    HERBALIFE

    SKIN Clearify

    Spot Treatment

    Salicylic Acid Acne Treatment

    0.5 fl oz (15 mL)

    01_Spot Treatment

  • INGREDIENTS AND APPEARANCE
    SKIN CLEARIFY SPOT TREATMENT 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51785-809
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
    CASTANEA SATIVA WHOLE (UNII: DK55N3C1AK)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51785-809-001 in 1 CARTON10/01/2016
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2016
    Labeler - Herbalife International of America Inc. (873035968)